DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/02/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 10/02/2025. As directed by the amendment: claims 1 have been amended and claims 2-3 have been cancelled. Thus, claims 1 and 4-10 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 5, filed 10/02/2025, with respect to the USC 112b rejections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the issues of clarity within the claims. The USC 112b rejections have been withdrawn.
Applicant's arguments, see pages 5-8, filed 10/02/2025, with respect to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Ostrovsky et al (US 20190374218 A1), herein referenced to as “Ostrovsky” in view of Brecher et al (US 20120143248 A1), herein referenced to as “Brecher” and Meade et al (US 20090024145 A1), herein referenced to as “Meade” have been fully considered but they are not persuasive.
The applicant has amended claim 1 to further recite “a first sliding groove and a second sliding groove”. The applicant asserts that the combination of the prior art of record does not teach this limitation. The examine respectfully disagrees.
The applicant argues that the combination of Brecher and Ostrovsky would not be obvious to one of ordinary sill in the art for three reasons.
The first reason is that the current invention has enhanced reliability and simplified control.
The second reason is that current invention has structural simplification and cost reduction.
The third reason is that the invention has synergistic operation for continuous suturing.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
As such the rejection of claim 103 will be maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-6, and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky et al (US 20190374218 A1), herein referenced to as “Ostrovsky” in view of Brecher et al (US 20120143248 A1), herein referenced to as “Brecher” and Meade et al (US 20090024145 A1), herein referenced to as “Meade”.
Claim 1
Ostrovsky discloses: A suture device 120 (see Figs. 4-5, [0087]), comprising: a main shell 121 (see Figs. 4-6, [0092]); a suture needle 122 (see Figs. 4-6 and 14-15, [0110]), wherein one end 1201 (see Figs. 14-15, [0110]) of the suture needle 122 is connected with a suture line 125 (see Fig. 15, [0110]), and the other end 1101 (see Fig. 14, [0110]) of the suture needle 122 is a tip pointed end (see [0110]); a needle feeding assembly 123 (see Figs. 7-9, [0095]) disposed on the main shell 121 and forming a separable engagement relationship (see [0103], engage and disengage with the needle) with the suture needle 122 to control advancement (see [0105], translated by the shuttle) of the suture needle 122; wherein the main shell 121 is provided with a first sliding groove 121c (see Fig. 7, [0095]) and a second sliding groove 121b (see Fig. 6, [0087]); the needle feeding assembly 123 comprises a pull cord 130 (see Fig. 8, [0070] and [0099]), an upper shell 601 (see Figs. 6-8, [0093]), a spring 126 (see Fig. 7, [0100] and [0102], 126 comprises a spring), a needle feeding tooth 124 (see Fig. 7, [0100]) and a sliding block 123 (see Fig. 7, [0100]), the pull cord 130 penetrates through the sliding block 123 (see Fig. 7, 130 passing through 123) and the upper shell 601 (see Figs. 4 and 6-8, the cord passes through 601 proximally), the needle feeding tooth 126 is mounted in the sliding block 123, one end (see [0102], In some embodiments, the cushion 126 presses against the pawl 124 to drive the pawl 124 upwards and out of the cavity 123A to engage the notch 122A…) of the spring 126 abuts against a surface (see [0102]) of the needle feeding tooth 124, the other end (see [0103], 126 is integrated into 123, and 123 abuts against 601, see [0096], the primary first housing portion 601 constrains a bottom surface of the shuttle 123) of the spring 126 abuts against the upper shell 601, the needle feeding tooth 124, the sliding block 123 and the spring 126 are mounted in the second sliding groove 121b (see Figs. 6-7) of the main shell 121, and the upper shell 601 covers (see annotated Fig. 7 below, additionally 601 covers 121b from in a superficial direction) the second sliding groove 121b; a lower shell 602 (see Figs. 6-7, [0096]) and the lower shell 602 is mounted in the first sliding groove 121c (see [0096], 602 comprises the shuttle guide/first sliding groove 121C) of the main shell 121.
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Ostrovsky does not explicitly disclose: and a needle anti-backoff assembly disposed on the main shell and forming a separable engagement relationship with the suture needle to prevent retraction of the suture needle; the needle anti-backoff assembly comprises a needle anti-backoff tooth, the lower shell and an elastic piece, the needle anti-backoff tooth is mounted at the lower shell, the needle anti-backoff tooth is mounted in the first sliding groove of the main shell, and the lower shell and the elastic piece are fixed to the main shell.
However, Brecher in a similar field of invention teaches a suture device 100 (see Fig. 4) with a main sell 106 + 108 (see Fig. 4), a suture needle 300 (see Figs. 6-16), a needle feeding assembly 160 (see Figs. 8-16). Brecher further teaches: and a needle anti-backoff assembly 115a/115b (see Figs. 13-16, [0078]) disposed on the main shell 106 + 108 and forming a separable engagement relationship (see [0078]-[0079]) with the suture needle 300 to prevent retraction (see [0078]-[0079]) of the suture needle 300.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ostrovsky to incorporate the teachings of Brecher and have the suture device with a needle anti-backoff assembly disposed on the main shell and forming a separable engagement relationship with the suture needle to prevent retraction of the suture needle. Motivation for such can be found in Brecher as this prevents the needle from moving in the opposite direction of its desired travel/actuation (see [0052] and [0066]).
The combination of Ostrovsky and Brecher does not explicitly teach: the needle anti-backoff assembly comprises a needle anti-backoff tooth, the lower shell and an elastic piece, the needle anti-backoff tooth is mounted at the lower shell, the needle anti-backoff tooth is mounted in the first sliding groove of the main shell, and the lower shell and the elastic piece are fixed to the main shell.
However, Meade in a similar field of invention teaches a suture device 70 (see Fig. 1, [0060]), comprising: a main shell 73 + 74 (see Figs. 2A-2B, [0063]) and a lower shell 74; a suture needle 110 (see Figs. 2A-2B and 4, [0062]-[0063]) with a first sliding groove 92 (see Figs. 6-7, [0076]) and a needle anti-backoff assembly 100 (see Figs. 6-8B, [0074]). Meade further teaches: the needle anti-backoff assembly 100 comprises a needle anti-backoff tooth 102 (see Figs. 6-8B, [0078]), the lower shell 74 and an elastic piece 104 (see Figs. 8A-8B, [0078]), the needle anti-backoff tooth 102 is mounted at the lower shell 74, the needle anti-backoff tooth 102 is mounted in the first sliding groove 92 (see Fig. 8B, 102 extends into the groove that contains 110, and 90 extends into the groove as well to contain the needle 110) of the main shell 73 + 74 (81 is an extension of the main shell), and the lower shell 74 and the elastic piece 104 are fixed to the main shell 73 + 74 (see Fig. 8B, 81 is an extension of the main shell).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination suture device of Ostrovsky and Brecher to incorporate the teachings of Meade and teach a suture device with the needle anti-backoff assembly comprises a needle anti-backoff tooth, the lower shell and an elastic piece, the needle anti-backoff tooth is mounted at the lower shell, the needle anti-backoff tooth is mounted in the first sliding groove of the main shell, and the lower shell and the elastic piece are fixed to the main shell. Motivation for such can be found in Meade as the anti-backoff tooth can additionally serve as a locking bar for the lower shell to allow the needle cartridge to be replaceable via a simple latch mechanism (see [0078]-[0079]).
Claim 4
The combination of Ostrovsky, Brecher, and Meade teaches: The suture device of claim 1, see 103 rejection above. Ostrovsky further discloses: wherein the main shell 121 comprises a first housing 601 (see Figs. 6-10, [0096]) and a second housing 602 (see Figs. 6-10, [0092]), the first housing 601 has a connecting slot the slot in which 603 is inserted (see Fig. 6), the second housing 602 has a connecting projection 603 (see Fig. 6, [0092]), and the connecting protrusion 603 is inserted into the connecting slot the slot in which 603 is inserted to connect the first housing 601 and the second housing 602 together.
Claim 5
The combination of Ostrovsky, Brecher, and Meade teaches: The suture device of claim 1, see 103 rejection above. Ostrovsky further discloses: A treatment device 100 (see Figs. 4-5, [0087]) and an operating handle 110 (see Figs. 1-2, [0071]), the operating handle 110 controlling the needle feeding assembly 123 to control the advancement 112 (see Figs. 1-3, [0107]) of the suture needle 122.
Claim 6
The combination of Ostrovsky, Brecher, and Meade teaches: The treatment device of claim 5, see 103 rejection above. Ostrovsky further discloses: further comprising a connecting ring 121A (see Figs. 4-5, [0087]) configured to be sleeved (see Figs. 4-5, [0087]) on the endoscope 140.
Claim 8
The combination of Ostrovsky, Brecher, and Meade teaches: The treatment device of claim 5, see 103 rejection above. Ostrovsky further discloses: further comprising a hook clamp 1701 (see Figs. 17-18, [0120]) configured to perform a clamping action onto tissue (will not be examined due to being an optional claim limitation, as recited as an alternate using the term “or”) or a hooking action (see Fig. 17, [0120]) of the suture line 125 at the distal end distal end of 140 of the endoscope 140.
Claim 9
The combination of Ostrovsky, Brecher, and Meade teaches: The suture device of claim 1, see 103 rejection above. Ostrovsky further discloses: A treatment system 100 (see Figs. 4-5, [0087]), comprising: an endoscope 140 (see Fig. 1, [0070]), a treatment device 100 for use with an endoscope 140, the treatment device 100 comprising the suture device as claimed in claim 1 (see and an operating handle 110 (see Figs. 1-2, [0071]), a suture device 120 (see Figs. 4-5, [0087]) secured to a distal end distal end of 140 of the endoscope 140, the operating handle 110 (see Figs. 1-2, [0071]) secured to an operating end proximal end of 140 of the endoscope 140, the operating handle 110 controlling the needle feeding assembly 123 to control the advancement 112 (see Figs. 1-3, [0107]) of the suture needle 122.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky in view of Brecher and Meade as applied to claims 5 and 9 above, and further in view of Okada (US 20050033115 A1), herein referenced to as “Okada”.
Claim 7
The combination of Ostrovsky, Brecher, and Meade teaches: The treatment device of claim 5, see 103 rejection above. The combination of Ostrovsky, Brecher, and Meade does not explicitly teach: further comprising a snare ring configured to perform a cutting action onto tissue at the distal end of the endoscope.
However, Okada in a similar field of invention teaches a treatment device 1 (see Figs. 1A) with an endoscope 16 (see Fig. 1A). Okada further teaches: further comprising a snare ring 42 (see Figs. 1A-4, [0039]) configured to perform a cutting action onto tissue (see Figs. 5A-5C, [0051]) at the distal end distal end of 16 (see Figs. 1-5C) of the endoscope 16.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ostrovsky to incorporate the teachings of Okada and have the treatment device further comprising a snare ring configured to perform a cutting action onto tissue at the distal end of the endoscope. Motivation for such can be found in Okada as this can be used to cut a sample of living tissue to be collected (see [0051]).
Claim 10
The combination of Ostrovsky, Brecher, and Meade teaches: The treatment system of claim 9, see 103 rejection above. Ostrovsky further discloses: further comprising a connecting ring 121A (see Figs. 4-5, [0087]) and a hook clamp 1701 (see Figs. 17-18, [0120]), wherein the connecting ring 121A is configured to be sleeved (see Figs. 4-5, [0087]) on the endoscope 140, and the hook clamp 1701 is configured to perform a clamping action onto the tissue and a hook action (see Fig. 17, [0120]) of the suture line 125 at the distal end distal end of 140 of the endoscope 140.
The language, "is configured to perform a clamping action onto the tissue," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Ostrovsky meets the structural limitations of the claim, and is capable of the hook clamp 1701 to be directed towards a section of tissue and clamped onto it as it has two pincer-like jaws.
The combination of Ostrovsky, Brecher, and Meade does not explicitly teach: a snare ring, the snare ring is configured to perform a cutting action onto tissue at the distal end of the endoscope.
However, Okada in a similar field of invention teaches a treatment device 1 (see Figs. 1A) with an endoscope 16 (see Fig. 1A). Okada further teaches: further comprising a snare ring 42 (see Figs. 1A-4, [0039]) configured to perform a cutting action onto tissue (see Figs. 5A-5C, [0051]) at the distal end distal end of 16 (see Figs. 1-5C) of the endoscope 16.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ostrovsky to incorporate the teachings of Okada and have the treatment system further comprising a snare ring configured to perform a cutting action onto tissue at the distal end of the endoscope. Motivation for such can be found in Okada as this can be used to cut a sample of living tissue to be collected (see [0051]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771